What does “off-label” mean?

Once the FDA approves a prescription medication, federal laws allow any U.S. physician to prescribe the duly approved drug for any reason. In fact, around 30 percent of all prescriptions are for off-label uses, written by American doctors exercising their medical judgment.

FDA-approved drugs like ivermectin may be prescribed for an unapproved use (“off-label”) when the physician believes it to be medically appropriate for their patients. The FDA affords clinicians the freedom to prescribe and treat using medications that they deem to be in the best interest of the patient.

The NIH COVID-19 Treatment Panel states that, “Providers can access and prescribe investigational drugs or agents that are approved or licensed for other indications through various mechanisms, including Emergency Use Authorizations (EUAs), Emergency Investigational New Drug (EIND) applications, compassionate use or expanded access programs with drug manufacturers, and/or off-label use.”

The panel also recommends that promising, unapproved, or unlicensed treatments for COVID-19 be studied in well-designed, controlled clinical trials. This includes drugs that have been approved or licensed for other indications. It is important to note that there have been multiple published, peer-reviewed controlled clinical trials throughout the world that point to the efficacy of ivermectin in the prevention and treatment of COVID-19.

The panel also stipulates that the treatment recommendations in their guidelines are not mandates, but rather that “the choice of what to do or not to do for an individual patient is ultimately decided by the patient and their provider.”

Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics, and devices according to their best knowledge and judgement. Doctors may prescribe what they wish as long as they believe themselves to be well-informed and basing their decision on sound medical evidence. It should be noted, however, that individual institutions may set their own standards for off-label prescriptions if they so choose.

To read more about off-label prescriptions, visit the list on www.fda.gov.